Fees Waived for COVID-19 Drug Licences

Summary#

The Establishment Licence Fees Remission Order (Indication of an Activity in respect of a COVID-19 Drug) (SOR/2020-213) remits (waives) certain fees that would normally be charged when someone applies for a drug establishment licence, an amendment, or an annual licence review — but only when the application is solely for activities related to a COVID‑19 drug under the Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19. The order came into force on September 28, 2020.

What it does#

• Waives the fee for Health Canada to examine one application for a new establishment licence or an amendment when the application plainly states it is only for activities related to a COVID‑19 drug under the Interim Order.
• Waives the fee for the annual review of an establishment licence, but only for each building or activity that is conducted solely for a COVID‑19 drug.
• Applies to buildings listed in Canada and to buildings located outside Canada that are part of an establishment licence tied to COVID‑19 drugs.
• Requires applicants to meet conditions:
  • The activities listed must be conducted solely for a COVID‑19 drug.
  • Applicants must provide documents on written request from Health Canada that show the activities are only for COVID‑19 drugs.
• If an applicant does not indicate the application is for a COVID‑19 drug (or later is found not to meet the conditions), the normal fees still apply.

Who's affected#

• Companies and people who apply for or hold drug establishment licences and who fabricate, package, label, import, test, distribute, or wholesale drugs that are used in relation to COVID‑19 under the Interim Order.
• Small businesses that run or plan to run COVID‑19 drug activities; the remission can reduce their upfront regulatory costs.
• Health Canada, which administers the remissions and may request documents to confirm eligibility.

If it’s unclear whether an application qualifies, applicants will need to check the conditions or contact Health Canada.

Why it matters#

• It lowers the immediate cost of getting or updating an establishment licence when those activities are only for COVID‑19 drugs. That can make it easier and faster for companies to start producing or handling those drugs in Canada.
• Faster licensing and fewer cost barriers can help increase the supply and availability of drugs used to treat, prevent, or mitigate COVID‑19.
• The relief is narrow and temporary: it only applies to licences and activities specifically tied to COVID‑19 drugs under the Interim Order, and authorizations under that Interim Order end when the Interim Order itself ends.